Levamlodipine

Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Experimental data suggest that amlodipine binds to both dihydropyridine and nondihydropyridine binding sites.

• CONJUPRI ® is calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.ICD-10: I10

• Levamlodipine is contraindicated in patients with known sensitivity to amlodipine. Known sensitivity to amlodipine.contraindicated

• Adult recommended starting dose: 2.5 mg once daily with maximum dose 5 mg once daily. ( 2.1 ) ○ Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 1.25 mg once daily. ( 2.1 ) • Pediatric starting dose: 1.25 mg to 2.5 mg once daily. ( 2.2 ) Important Limitation : Doses in excess of 2.5 mg daily have not been studied in pediatric patients. ( 2.2 ) 2.1 Adults The usual initial antihypertensive oral dose of levamlodipine is 2.5 mg once daily, and the maximum dose is 5 mg once daily. Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 1.25 mg once daily and this dose may be used when adding levamlodipine to other antihypertensive therapy. Adjust dosage according to blood pressure goals. In general, wait 7 to 14 days between titration steps. Titrate more rapidly, however, if clinically warranted, provided the patient is assessed frequently. 2.2 Children The effective antihypertensive oral dose in pediatric patients ages 6–17 years is 1.25 mg to 2.5 mg once daily. Doses in excess of 2.5 mg daily have not been studied in pediatric patients [see Clinical Pharmacology ( 12.4 ), Clinical Studies ( 14.1 )] .

Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. However, acute hypotension is unlikely. ( 5.1 ) Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine, particularly in patients with severe obstructive coronary artery disease. ( 5.2 ) Titrate slowly in patients with severe hepatic impairment. ( 5.3 ) 5.1 Hypotension Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely. 5.2 Increased Angina or Myocardial Infarction Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine, particularly in patients with severe obstructive coronary artery disease. 5.3 Patients with Hepatic Failure Because amlodipine is extensively metabolized by the liver and the plasma elimination half-life (t 1/2 ) is 56 hours in patients with impaired hepatic function, titrate slowly when administering amlodipine to patients with severe hepatic impairment.

Most common adverse reactions to amlodipine is edema which occurred in a dose related manner. Other adverse experiences not dose related but reported with an incidence >1.0% are fatigue, nausea, abdominal pain and somnolence. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, call CSPC Ouyi Pharmaceutical Co., Ltd at 1-877-436-7220 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Amlodipine has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. In general, treatment with amlodipine besylate was well-tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with amlodipine were of mild or moderate severity. In controlled clinical trials directly comparing amlodipine besylate (N = 1730) at doses up to 10 mg to placebo (N = 1250), discontinuation of amlodipine besylate because of adverse reactions was required in only about 1.5% of patients and was not significantly different from placebo (about 1%). The most commonly reported side effects more frequent than placebo are reflected in the table below.

Pediatric: Effect on patients less than 6 years old is not known. ( 8.4 ) Geriatric: Start dosing at the low end of the dose range. ( 8.5 ) 8.1 Pregnancy Risk Summary The limited available data based on post-marketing reports with amlodipine use in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy [see Clinical Considerations] . In animal reproduction studies, there was no evidence of adverse developmental effects when pregnant rats and rabbits were treated orally with amlodipine during organogenesis at doses approximately 10 and 20-times the maximum recommended human dose (MRHD), respectively. However for rats, litter size was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly increased (about 5-fold). Amlodipine has been shown to prolong both the gestation period and the duration of labor in rats at this dose [see Data] . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S.

Metabolism

The exposure (Cmax and AUC) of levamlodipine is similar between CONJUPRI ® 5 mg and Norvasc® (amlodipine besylate) 10 mg under fasting condition. Absorption After oral administration of CONJUPRI ® , absorption produces peak plasma concentrations between 6 and 12 hours.

Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. In humans, experience with intentional overdosage of amlodipine limited. Single oral doses of amlodipine equivalent to 40 mg amlodipine/kg and 100 mg amlodipine/kg in mice and rats, respectively, caused deaths. Single oral amlodipine maleate doses equivalent to 4 or more mg amlodipine/kg or higher in dogs (11 or more times the maximum recommended human dose on a mg/m 2 basis) caused a marked peripheral vasodilation and hypotension. If massive overdose should occur, initiate active cardiac and respiratory monitoring. Frequent blood pressure measurements are essential. Should hypotension occur, provide cardiovascular support including elevation of the extremities and the judicious administration of fluids. If hypotension remains unresponsive to these conservative measures, consider administration of vasopressors (such as phenylephrine) with attention to circulating volume and urine output. As amlodipine is highly protein bound, hemodialysis is not likely to be of benefit.

• Dec 19, 2019NDANDA212895Cspc Ouyi

1. 1Diarrhoea129.9%
2. 2Fatigue86.6%
3. 3Hypertension86.6%
4. 4Nausea86.6%
5. 5Arthralgia75.8%
6. 6Drug Ineffective75.8%
7. 7Hypoaesthesia75.8%
8. 8Malaise75.8%
9. 9Pain75.8%
10. 10Pneumonia75.8%
11. 11Constipation65.0%
12. 12Decreased Appetite65.0%
13. 13Dyspnoea65.0%
14. 14Off Label Use65.0%
15. 15Pain In Extremity65.0%

The 10 most recently updated of 43 ClinicalTrials.gov registrations naming Levamlodipine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Clinical Study Comparing Ankle Swelling Caused by Two Different Blood Pressure Medications, Levamlodipine and Amlodipine, in Post-menopausal Women With Mild High Blood Pressure.
  Not yet recruiting · Phase 3 · Interventional · 344 enrolled · Zentiva, k.s.
  NCT07618806updated 2026-06-01
• A Phase III Clinical Trial Evaluating the Efficacy and Safety of Valsartan/Levamlodipine (SYH9056) Tablets In Hypertensive Patients
  Not yet recruiting · Phase 3 · Interventional · 606 enrolled · CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
  NCT06771245updated 2025-01-13
• Drug-Drug Interaction Study Between HUC2-565-A and HUC2-565-B
  Active not recruiting · Phase 1 · Interventional · 46 enrolled · Huons Co., Ltd.
  NCT06618079updated 2024-10-01
• Efficacy and Safety of Mexartan Potassium Tablets (AZL-M) and Calcium Channel Blockers (CCB) in the Treatment of Adults With Essential Hypertension in Chinese Population: a National Multicenter, Prospective, Observational Study
  Unknown · Observational · 1,215 enrolled · Hasten Biopharmaceutical Co., Ltd.
  NCT05947448updated 2024-04-01
• An Observation Study on the Identification of Prescription Patterns of Lodient Tab(Telmisartan/S-amlodipine)
  Unknown · Observational · 4,000 enrolled · Hanlim Pharm. Co., Ltd.
  NCT06214832updated 2024-01-22
• S-amlodipine in Essential HypertensIon and Assessment of Blood Pressure Targets Achievement
  Unknown · Observational · 5,000 enrolled · Hanlim Pharm. Co., Ltd.
  NCT06130124updated 2023-11-14
• Analysis of Factors Influencing the Efficacy of Levamlodipine Benzoate and Its Population Pharmacodynamic Modeling
  Unknown · Observational · 150 enrolled · The Second Affiliated Hospital of Chongqing Medical University
  NCT05958524updated 2023-09-14
• Population Pharmacokinetic - Pharmacodynamic Models of Chronic Disease Therapeutics for Smokers
  Unknown · Observational · 200 enrolled · The Second Affiliated Hospital of Chongqing Medical University
  NCT05126381updated 2023-06-18
• A Clinical Trial to Evaluate the Blood Pressure Control of Telmisartan or Losartan in Essential Hypertensive Patients With Metabolic Syndrome
  Unknown · Phase 4 · Interventional · 116 enrolled · Chong Kun Dang Pharmaceutical
  NCT05843162updated 2023-05-06
• Efficacy and Safety of Leningrado Association in the Treatment of Hypertension
  Withdrawn · Phase 3 · Interventional · 0 enrolled · EMS
  NCT03814109updated 2022-07-27

Frequently asked questions

How does Levamlodipine work?

Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Experimental data suggest that amlodipine binds to both dihydropyridine and nondihydropyridine binding sites.

What is Levamlodipine used for?

According to FDA labeling, Levamlodipine carries indications including: CONJUPRI ® is calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Levamlodipine?

Levamlodipine is classified as Dihydropyridine derivatives, Calcium Channel Antagonists, Arterial Vasodilation.

What are the brand names for Levamlodipine?

Levamlodipine is marketed under brand names including Conjupri.

What are the contraindications for Levamlodipine?

Levamlodipine labeling lists contraindications including: Levamlodipine is contraindicated in patients with known sensitivity to amlodipine. Known sensitivity to amlodipine.. Always consult the full prescribing information and a clinician.